Innovative Cellular Therapeutics Co., Ltd.

2016/5/9 15:42


AsiaNet 64337(0567)

【杭州(中国)2016年5月6日PR Newswire=共同通信JBN】


4月22日から24日まで杭州で開催された2016年血液免疫サミット(2016 Haematogenic Immunity Summit)で、浙江大学第1附属病院のフアン・ヘ教授は白血病治療のためにCAR-T細胞療法を使った10件の臨床例の結果について報告した。この臨床試験の完全なデータが公表されたのはこれが初めてである。

Photo - http://photos.prnasia.com/prnh/20160506/0861604035


同病院とInnovative Cellular Therapeutics(ICT)社が共同で実施したこの試験は、臨床倫理の承認を得ており、2015年6月に最初の患者を登録した。2016年4月までに10人目の患者が完全寛解を達成した。





Innovative Cellular Therapeuticsは浙江大学第1附属病院と協力してCAR-T療法の進化の成功を実現した。ICTはこのほかに中国の7カ所の病院で再発性、難治性の急性リンパ芽球性白血病患者を対象に臨床試験を行っており、この病気が進行した段階にある23人の患者について試験と初期データの収集を完了した。試験対象患者の87%に当たる20人の患者が白血病の完全寛解を達成した。

この試験の前に、同水準の白血病のCAR-T療法を開発したのは、世界で3社(いずれも米国に本社を置くノバルティス、Juno、Kite Pharma)だけだった。中国企業のICTは今、この優れたグループに加わり、CAR-T療法適用の世界的リーダーの1つになった。



ソース:Innovative Cellular Therapeutics Co., Ltd.

Complete Remission Rate of 90%: China-based CAR-T Cell Therapy Achieves Breakthrough Clinical Trial Results


HANGZHOU, China, May 6, 2016 /PRNewswire=KYODO JBN/ --

- The First Affiliated Hospital of Zhejiang University reports on CAR-T

clinical trials results for the treatment of leukemia

At the 2016 Haematogenic Immunity Summit held in Hangzhou from April 22 to 24,

2016, Professor Huang He from the First Affiliated Hospital of Zhejiang

University presented on the results for ten clinical cases that used CAR-T cell

therapy for the treatment of leukemia. This is the first time that the complete

data set from the clinical trials was made publicly available.

Photo - http://photos.prnasia.com/prnh/20160506/0861604035

The trial, jointly conducted by the hospital and the company Innovative

Cellular Therapeutics (ICT), obtained clinical ethics approval and enrolled its

first patient in June 2015. By April 2016, the tenth patient achieved complete


During the 10 months of the trial, the research team finished CAR-T cell

reinfusion and conducted preliminary evaluation of ten patients suffering from

relapsed or refractory B lymphoblastic leukemia.

The clinical trial was conducted in strict accordance with clinical ethical

standards and monitored independently by a third-party clinical research

organization. All patient expenses incurred by the CAR-T trial were reimbursed

by ICT. Nine out of the ten patients achieved complete remission, and the

minimal residual disease (MRD) in 8 patients turned negative, a significant

indication of curative effect. Both the complete remission rate of 90% and the

MRD-negative rate of 80% out-performed the best results recorded worldwide to


All ten patients, ranging in age from 17 to 57, suffered from relapsed or

refractory B lymphocytic leukemia and were expected to live only several

months. The tenth and final patient is a 17-year-old female who enrolled in the

CAR-T clinical trial in March of this year. After collecting her blood,

researchers performed a genetic transformation of her common T-cells to express

a molecule called Chimeric Antigen Receptor (CAR). Similar to GPS, CAR can

guide specific T-cells to track, identify and kill malignant tumor cells.

Through the application of this technology, common T-cells were transformed

into "cancer fighting" CAR-T cells.

In early April 2016, the transformed CAR-T cells were infused into the body of

the patient, and the 'cytokine storm' took place as the research team had

expected. As the CAR-T cells rapidly proliferated in the patient's body and

released a large number of cytokines, the patient experienced symptoms that

included fever, muscle pain and hypoxemia. These symptoms indicated that the

introduction of CAR-T cells was having a positive effect. The subsequent test

results showed that she was in complete remission and she was identified as


Innovative Cellular Therapeutics, in collaboration with the First Affiliated

Hospital of Zhejiang University, achieved success in the evolution of CAR-T

therapy. ICT is conducting clinical trials on relapsed and refractory acute

lymphocytic leukemia in seven other hospitals across China and has completed

the trial and initial data collection of 23 patients suffering from an advanced

stage of the disease. Twenty patients, or 87% of the total trial population,

enjoyed complete remission of leukemia.

Before the trial, only three firms in the world (Novartis, Juno and Kite

Pharma), all based in the U.S., have developed similar levels of CAR-T therapy

for leukemia. ICT, a Chinese firm, has now joined that distinguished group to

become one of the global leaders in the application of CAR-T therapy.

Based on the success of its leukemia trial, ICT will next set its sights on a

new clinical trial for the treatment of lymphoma. Looking ahead, ICT will focus

its R&D efforts on solid tumors including colorectal cancer, breast cancer,

gastric cancer and esophageal cancer.

CAR-T cellular therapy is rapidly gaining the attention of doctors,

researchers, patients, and the public at large as the most promising tumor

precision therapy in the world and it is expected to benefit more patients

afflicted with tumors in the future.

Source: Innovative Cellular Therapeutics Co., Ltd.